4-N-1 Skin Protectant recalled over manufacturing violations

Recall date

August 27, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

DermaRite Industries, LLC recalls 4-N-1 Skin Protectant, No Rinse Wash Cream with Dimethicone 1%, 113g, (4 oz) per bottle, DermaRite Industries LLC, 7777…

Recall number

D-0160-2026

FDA classification

Class II

Brand / firm

DermaRite Industries, LLC

Sold / distributed

Nationwide in the USA

Why it was recalled

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

4-N-1 Skin Protectant, No Rinse Wash Cream with Dimethicone 1%, 113g, (4 oz) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-208-04